Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy

NCT ID: NCT00172055

Last Updated: 2017-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2009-07-31

Brief Summary

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The objective of the study is to investigate whether blood markers can be used to predict the development of bone metastases and to assess the efficacy and safety of zoledronic acid in cancer treatment induced bone loss.

Detailed Description

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Conditions

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Cancer Prostate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ZOL446 (zoledronic acid)

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

Interventions

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Zoledronic acid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All stages of prostate cancer without bone metastases
* No evidence of severe osteoporosis
* ECOG performance status 0, 1 or 2

Exclusion Criteria

* Surgery / fracture at the lumbosacral spine, bilateral hip implants
* Evidence of metabolic bone diseases,
* Treatment with bisphosphonates or calcitonin within the previous year or chronic systemic corticosteroid treatment
* Abnormal kidney or liver function
* Other cancers within the last 5 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

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Novartis Investigative Site

Anderlecht, , Belgium

Site Status

Novartis Investigative Site

Antwerp, , Belgium

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Novartis Investigative Site

Bruges, , Belgium

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Novartis Investigative Site

Brussels, , Belgium

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Novartis Investigative Site

Charleroi, , Belgium

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Novartis Investigative Site

Edegem, , Belgium

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Novartis Investigative Site

Ghent, , Belgium

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Novaris Investigative Site

Gosselies, , Belgium

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Novartis Investigative Site

Kortrijk, , Belgium

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Novartis Investigative Site

Leper, , Belgium

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Novartis Investigative Site

Leuven, , Belgium

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Novaris Investigative Site

Libramont, , Belgium

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Novartis Investigative Site

Mont-Godinne, , Belgium

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Novartis Investigative Site

Roeselare, , Belgium

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Novartis Investigative Site

Tongeren, , Belgium

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Novartis Investigative Site

Tournai, , Belgium

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Novartis Investigative Site

Turnhout, , Belgium

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Novartis Investigative Site

Wilrijk, , Belgium

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Novartis Investigative Site

Woluwe-Saint-Lambert, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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CZOL446GBE03

Identifier Type: -

Identifier Source: org_study_id

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